Patient care system for critical medications

ABSTRACT

A patient care system has a medical pump for delivering a medicine to a patient, and a processor in communication with the pump. The pump is configured to receive a first input on whether the medicine is a critical medicine, and a second input on a trigger condition that triggers a fail-operate mode for the critical medicine. The processor controls the medical pump to operate in the fail-operate mode, where the fail-operate mode continues delivery of the critical medicine when the trigger condition is triggered.

BACKGROUND OF THE INVENTION

Infusion pumps are used for intravenous delivery of medicines such asinsulin, analgesics, sedatives, vasopressors, heparin andanti-arrhythmics to patients. Correct delivery of these medications isimportant for avoiding adverse events, particularly in critically illpatients. Smart infusion pumps, which include drug libraries andintegrated decision support software in their medication deliverysystems, have decreased errors in administration of medications byincorporating features such as hard and soft alarm limits, clinicianmessaging, and medication barcode input. Smart pumps are also able toutilize electronic medical records and inputs customizable for specificcare units to improve safety for individual patients. Other infusionsystems have incorporated features for a specific disease, such asalgorithms to change the rates of insulin delivery based on a patient'sglucose level, or to offer procedures specifically for advanced cardiaclife support.

Yet, smart pumps are still subject to human programming errors andlimited response times of busy clinicians. There remains a need toimprove the ability for infusion pumps to provide safe delivery ofmedicines to patients, particularly in the case of critically illpatients where delivery of a medicine is life-sustaining.

SUMMARY OF THE INVENTION

A patient care system has a medical pump for delivering a medicine to apatient, and a processor in communication with the pump. The pump isconfigured to receive a first input on whether the medicine is acritical medicine, and a second input on a trigger condition thattriggers a fail-operate mode for the critical medicine. The processorcontrols the medical pump to operate in the fail-operate mode, where thefail-operate mode continues delivery of the critical medicine when thetrigger condition is triggered.

BRIEF DESCRIPTION OF THE DRAWINGS

Each of the aspects and embodiments of the invention described hereincan be used alone or in combination with one another. The aspects andembodiments will now be described with reference to the attacheddrawings.

FIG. 1 shows an exemplary infusion pump in the art;

FIG. 2 is a schematic diagram of a typical medication delivery system;

FIG. 3 is an exemplary flowchart of general infusion pump operationknown in the art;

FIG. 4 is a flowchart of an exemplary fail-operate infusion pump in oneembodiment;

FIG. 5 shows an exemplary drug input screen for a fail-operate medicalpump; and

FIG. 6 depicts an optional confirmation screen for an exemplaryfail-operate mode.

DETAILED DESCRIPTION OF THE EMBODIMENTS

A method and system to allow infusion pumps to provide additional safetyfactors based on the type of drug being infused is disclosed. Forcertain patients and in certain care areas, the drug being infused islife-sustaining. In most failure or alarm modes of infusion pumps, thepump is designed to display an alarm and stop infusing when a particularcondition is triggered in order to protect the patient from the failure.However, if the infusion is life-sustaining, this cessation in thedelivery of the drug—referred to as a “fail-stop” condition in thisdisclosure is likely to be more harmful than the potential risk of thealarm condition itself. In the present invention, a “fail-operate” modeis provided in which the pump continues infusing when the alarmcondition is present. A clinician or pharmacist is enabled to identifycritical drugs used in critical infusions, allowing the medications tosustain the patient while the alarm condition is present. Thefail-operate mode, also referred to as a “keep infusing” mode in thisdisclosure, may be chosen for a certain care area in a hospital, and/orto be specific to a particular patient. This disclosure describescontrols and methods of use to provide the clinician with thecapabilities to customize particular alarm conditions to perform in afail-operate mode rather than the normal fail-stop alarm conditionresponse.

FIG. 1 shows an exemplary infusion pump 100, which includes aprogramming screen 110 and a cassette carriage 120 for loading aninfusion administration set or line. The programming screen 110 is atouch screen in this embodiment, which allows a user to input or viewvarious delivery data such as infusion settings and patient information.In addition, a menu bar 130 at the bottom of screen 110 includes buttonswith which a professional caregiver may enter information or change astatus regarding modes, settings, logs, locks, and alarms.

FIG. 2 illustrates a schematic diagram 200 of a typical medicationdelivery system, also referred to in the art as a medication managementsystem. A caregiver 210 provides input through an input device 220, suchas the programming screen 110 of FIG. 1, to enter delivery informationand adjust settings as needed. The input device 220 stores informationin a processor memory 230. A network interface 240, such as a HospiraMedNet™ platform, may also input information to memory 230. For example,network interface 240 may be in communication with a hospitalinformation system or network, which may include a medicationadministration record system, pharmacy information system, or barcode-enabled point-of-care system. A processing logic system 250utilizes information from processing memory 230 to control medicationdelivery pump 260, which infuses the desired fluids to the patient 270.The pump 260 may optionally include an indicator light 280 and/or anaudible alarm 290 to provide sensory output indicating, for instance,when the infusion is in process or when an alarm condition occurs. Thepump 260 may provide feedback to the logic system 250, such as withpatient physiological parameters or pump failure parameters, so that thelogic system 250 can monitor for the presence of any alarm thresholds.

FIG. 3 is a flowchart 300 illustrating a general method of operation ofsmart infusion pumps known in the art. An infusion pump processor 310receives drug library input 312 including customizable alarm limits viaa central network. An infusion pump processor may also receive optionalinputs such as basic patient data (e.g., weight, age) at a point of careof the patient. A medical caregiver may also input the clinical careareas (CCA) in which the pump is being used, in step 315. A caregiverthen “fills the infusion order” by electronically downloading pumpprogramming parameters via the network and/or manually programming thepump via the input device to deliver an infusion order for a patient instep 320, and the medication is delivered in step 330. In step 340, theprocessor checks whether an alarm condition is present. This alarmcondition can be triggered when a failure of the pump occurs, such asocclusion in the delivery line, air-in-line, or low battery. Alarmthreshold levels, such as for air in the infusion tubing, may bepredetermined by the pump manufacturer, customized by a physician,biomed, pharmacist or other caregiver or they may be pre-set in the druglibrary. If the alarm condition is triggered, the pump stops delivery ofthe medicine in step 350. When failure occurs, an alert 360 may be sent.The alert may be in the form of an alarm sound or an electronic signalor message sent to a caregiver or physician to respond to the alarm. Ifno alarm condition is present, delivery of the drug continues.

Discontinuing delivery when a failure occurs, as in conventional smartpumps, is designed to protect the patient from potential adverseconsequences of a pump “failure” or alarm condition. However, forcritical drugs, discontinuing delivery may in fact harm a patient andeven be life-threatening. Moreover, clinicians may not be immediatelyavailable to attend to a patient in such a case. Current infusionsystems are designed to fail-stop, requiring critical, life-sustaininginfusions to be carefully monitored by busy clinicians to preventpotentially noisy, annoying nuisance alarms from stopping the infusionuntil the alarm can be cleared.

FIG. 4 is a flowchart 400 of one embodiment of the present disclosure inwhich a user is beneficially provided with an option to allow a drug tokeep infusing in the presence of an alarm condition. In step 410, amedical professional such as a pharmacist or physician may identify ordesignate a drug in a drug library as a critical medicine. This inputmay be performed by, for example, calling up the drug library, selectingthe desired medication, and clicking a toggle box associated with themedication to indicate that the drug is a critical medicine.Alternatively, the input may be performed by a medical professional or acaregiver through a touch screen on the pump, through keyboard or touchentry. One or more drugs may be specified in this input step. In someembodiments, a possible list of critical drugs may be provided by thedrug library database, and the caregiver or medical professional mayselect or confirm particular drugs from this list. The critical druginput is then stored in memory as part of the drug library information.Critical drugs may include, for example, anticoagulants (e.g., heparin),saline or other fluids for hydration, nutrient solutions, andantibiotics. This selection of particular drugs in step 410 beneficiallyenables, via later steps described below, customized care for anindividual patient based on their medical condition.

In step 420, trigger conditions at which a fail-operate mode are desiredto be activated for the critical drug are input by a medicalprofessional such as a pharmacist or physician. In some embodiments thetrigger conditions may be standard alarm conditions, which may includean occlusion, air-in-line, or low battery. The conditions may beselected through, for example, a drop down menu in which a user selectsto edit an alarm condition, and an editing screen then provides a togglebox to engage the fail-operate mode for that condition. In otherembodiments the user may have the option to override all alarmconditions. In yet further embodiments, the user may have the option toadjust threshold values for the alarm, such as for an amount of airallowed to pass in the infusion line.

In step 430, drug library information 432, including the criticalmedicine information 410 and trigger condition information 420, isprogrammed into the processor. Optionally, patient data 434 may also beinput, including the patient's medical history, recent medicaltreatments, and medical conditions such as monitored or testedphysiological parameters related to critical drug infusions. The inputs432 and 434, as well as subsequent inputs of flowchart 400, are storedin the memory of the processor, which is in communication with theinfusion pump.

In step 440, a medical caregiver may also input one or more specificclinical care areas (CCA) in which the selected drug(s) may be used as acritical infusion. The ability to select or customize at the druglibrary particular CCA's in which the fail-operate mode is allowed forthe critical drug enables further safety and customization for patients.For example, a certain antibiotic may be life-sustaining in an emergencyroom setting, while in a pediatric area it would be allowable to stopadministration of the antibiotic without creating a life-threateningsituation to the patient.

In some embodiments, the identification of a particular drug as acritical medicine in step 410 will automatically activate thefail-operate mode, when that drug is delivered. In other embodiments, aprofessional caregiver—such as the pharmacist or physician—may beallowed to choose whether to engage the fail-operate mode, as shown inoptional step 450. This option may be useful, for example, to allow aphysician to choose the fail-operate mode depending on the patient'scondition. In some embodiments, the fail-stop mode may remain thedefault mode, even when settings for a fail-operate mode have beenentered (e.g., in steps 410, 420, 440), unless activation of thefail-operate mode is confirmed before delivery. The options ofcustomizing the fail-operate mode for particular critical drugs, forparticular CCA's, and for particular patients, beneficially enablesclinically targeted selection of the fail-operate mode for criticalinfusions. Additionally, enabling the physician to choose whether toengage the fail-operate mode provides even further safety to the patientcompared to current infusion systems which operate only by stoppinginfusion when an alarm is triggered.

Still referring to FIG. 4, after the fail-operate conditions have beenestablished, the infusion pump is ready to deliver medication. Uponreceiving an order, a nurse programs the infuser to fill the order instep 460. During programming, the nurse may be informed by the deliverypump that the drug is a critical drug, and may optionally be presentedwith a confirmation screen in step 465 to confirm whether the infusionpump will use the fail-operate mode. The confirmation process mayinclude a listing of the alarm conditions that will trigger thefail-operate mode. After filling the order, the medication is deliveredin step 470. If an alarm condition is detected during infusion, theprocessor's logic system will determine in step 480 whether the Omnicondition is one of the selected fail-operate trigger conditions. If thetrigger condition is present, the infuser will provide an indication instep 495 that the trigger condition has been activated, but willcontinue to infuse if possible in step 490. Infusion typically willcontinue at the same rate as its existing rate. If the pump is unable tocontinue delivery, for example because of a fully blocked infusion line,it may be programmed to return to the fail-stop mode. In anotherembodiment, the infusion may continue but at a reduced non-zero rate.

Various indicators may be utilized in step 495 to alert personnel whenthe fail-operate mode is active. In some embodiments, triggering of thefail-operate mode may initiate an audible alarm, such as a single toneor a melody, where the sound for the fail-operate mode is different fromthat of the normal fail-stop mode. This differentiation in alarm soundbeneficially alerts a caregiver that a fail-operate alarm conditionexists, and that delivery of the critical medication is continuing. Inother embodiments, triggering of the fail-operate mode may activate analert light on the pump, display a text message on the pump's screenmonitor, or send a signal or message notification to a clinician or amobile communication device carried by the clinician. One or more of theindicators described herein may be used simultaneously. After thefail-operate mode has been engaged, the caregiver may locally clear thecause of the alarm condition and continue the infusion.

FIG. 5 shows an exemplary drug library editing screen 500, such as mightappear on a display screen associated with a network interface such as aprocessor equipped with Hospira MedNet™ software would occur in steps410 and 420 of FIG. 4. Editing screen 500 includes standard customizablefields, such as medication amount and dosing rate, for the drug dopaminewhich is used in this example. In the embodiment of FIG. 5, editingscreen 500 includes a fail-operate input field 510 which allows the userto select “Enable Keep Infusing Mode” to engage the tail-operatecondition. Selection in this embodiment is performed through marking atoggle box. In other embodiments, a user may be presented with thechoice of “Keep Infusing” and “Stop Infusing” modes, and asked tohighlight their desired choice, where the default may be shown as “StopInfusing.” The user can further select one or more trigger alarmconditions in the subfield 520, which includes single air bubble, airaccumulator, proximal occlusion, distal occlusion, and depleted batteryin this example. This subfield 520 may be used, for example, in relationto step 420 of FIG. 4, and may further include a subsequent screen toinput values associated with a particular condition. For example, afterselecting “air accumulator,” the system may prompt the user o alter anallowable value of air accumulated, or to utilize a standard pre-setvalue.

FIG. 6 shows an exemplary confirmation screen 600 at the pump 100, aswould be used in association with steps 440 and 450 of FIG. 4. When anurse fills an order for a drug, which again is shown as dopamine inthis example, a pop-up screen 610 or other visual or audio signalnotifies the nurse that the “Keep Infusing Mode” has been allowed. Thenurse can then confirm whether to continue with the “Keep Infusing Mode”by selecting a yes or no response, and the system may be programmed tonot proceed until the response is entered. The pop-up screen 610 in thisexample also lists information about the conditions that have been setfor the Keep Infusing Mode. In some embodiments, the pop-up screen maybe accompanied by an audible tone to alert the caregiver to verify theinformation on the display, to increase awareness to the caregiver thatthe pump has been programmed to operate in a different mode.

Various alarm or failure conditions are possible for triggering afail-operate condition. For example, “fail-operate” could be used tocontinue delivery of a critical medication when air is present in thedelivery line. In some pumps, there are two types of “air-in-line”alarms—single bubble and accumulated. Single bubble alarms are typicallyrestricted in the drug library or in the pump code to approximately50-500 microliters of air before alarming. Accumulated air alarms aretypically set on the order of 1000 microliters, as many patients areable to withstand more than a single bubble before harm occurs. In oneembodiment, a fail-operate mode may be allowed to override the singlebubble alarm and enable critical drug infusion to continue if thepatient. Allowing a single bubble to pass may be more beneficial to thepatient than halting delivery of a life-sustaining medicine, as thepatient is still protected by the accumulated air alarm.

In another embodiment, an occlusion condition may operate in thefail-operate mode. Occlusions may occur when, for example, there is akink in the infusion tubing, or when the tubing has been improperlyloaded. The fail-operate mode allows the critical medication to continuebeing delivered, even at a partial rate due to a blockage in the tosustain the patient rather than stopping delivery until the line isfixed.

In another embodiment, the designation of a medication as a criticalmedication in a drug library can be optional and the medication cansimply be flagged in the drug library downloaded to the pump or thememory resident in the pump as designated for delivery in a fail-operatemode. This embodiment provides a patient care system that includes amedical pump for delivering a medicine to a patient and a processor incommunication with the medical pump. The processor has a memory andlogic adapted to: 1) receive a first input on whether the medicine isallowed to be delivered in a fail-operate mode; and 2) receive a secondinput on a trigger condition that triggers the fail-operate mode. Thefail-operate mode provides for continuation of the delivery of themedicine when the trigger condition is triggered. The first input andthe second input are stored in the memory. The pump is controlled tooperate in the fail-operate mode for the flagged medicine when thetrigger condition is triggered. Manufacturers, institutions or users mayflag only some drugs, flag entire drug libraries, all drugs in certainCCAs, or all drugs in certain pumps to be delivered in a fail-operatemode.

While the specification has been described in detail with respect tospecific embodiments of the invention, it will be appreciated that thoseskilled in the art, upon attaining an understanding of the foregoing,may readily conceive of alterations to, variations of, and equivalentsto these embodiments. These and other modifications and variations tothe present invention may be practiced by those of ordinary skill in theart, without departing from the scope of the present invention.Furthermore, those of ordinary skill in the art will appreciate that theforegoing description is by way of example only, and is not intended tolimit the invention. Thus, it is intended that the present subjectmatter covers such modifications and variations.

1-20. (canceled)
 21. A method of operating an infusion pump configuredto deliver a drug to a patient, the method comprising: receiving a firstinput designating the drug as a critical medicine; receiving a triggercondition where a fail-operate mode during delivery of the drug can beselected; storing the drug as critical medicine in the memory; storingthe trigger condition with respect to the drug in the memory where thefail-operate mode during delivery of the drug can be selected;generating a first graphical user interface including an input fieldconfigured to enable a user to select the fail-operate mode duringinfusion of the drug stored as critical medicine; including the storedtrigger condition in the first graphical user interface; receiving theuser selection for activation of the fail-operate mode for the storedtrigger condition; determining whether an alarm condition for the userselected trigger condition is activated; and in response to thedetermination of the activated alarm condition, generating an alarmcorresponding to the alarm condition and continue delivery of the drugduring the alarm condition based on the user selection to activate thefail operate mode for the trigger condition.
 22. The method of claim 21,further comprising operating the medical pump in a fail-stop mode as adefault mode of operation.
 23. The method of claim 22, wherein the alarmcondition comprises a first audible alarm, and wherein the first audiblealarm is different than a second audible alarm for the fail-operatemode.
 24. The method of claim 21, further comprising requestingconfirmation for engaging the fail-operate mode.
 25. The method of claim24, wherein the confirmation is presented by a graphical user interfaceon a display of the medical pump.
 26. The system of claim 21, whereinthe first input is received electronically from an electronic druglibrary or a professional caregiver.
 27. The system of claim 21, whereinthe second input is received electronically from an electronic druglibrary or a professional caregiver.
 28. The system of claim 21, whereinthe trigger condition is configured to be specific to an individualpatient or to a specific clinical care area.
 29. The system of claim 21,wherein the trigger condition is selected from the group consisting ofan occlusion, air-in-line, air accumulation, and low battery.
 30. Thesystem of claim 21, wherein the critical medicine is selected from thegroup consisting of: an anticoagulant, a hydration fluid, a nutrientsolution, and an antibiotic.
 31. The system of claim 21, furthercomprising generating an indication of when the fail-operate mode isengaged, wherein the indication is selected from the group consistingof: a notification to a medical professional, a message displayed on themedical pump, an audible tone, and an indicator light.
 32. A method ofoperating an infusion pump configured to deliver a drug to a patient,the method comprising: generating a first graphical user interfaceincluding an input field configured to enable a user to select afail-operate mode during infusion of the drug designated as criticalmedicine; receiving the user selection for activation of thefail-operate mode for one or more trigger conditions; and delivering thedrug during an alarm condition based on the user selection to activatethe fail operate mode for the one or more trigger conditions.
 33. Themethod of claim 32, wherein a fail-stop mode is a default mode ofoperation.
 34. The method of claim 32, wherein the alarm conditioncomprises a first audible alarm, and wherein the first audible alarm isdifferent than a second audible alarm for the fail-operate mode.